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临床试验/NCT07771244
NCT07771244尚未招募不适用

Assessment of Injectable Hyaluronic Acid Combined With Polynucleotides With Coronally Advanced Flap and Connective Tissue Graft in Treatment of RT II Gingival Recession Defects for Covering Gingival Recession

Cairo University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
12
试验地点
1
主要终点
Percentage of Root Coverage

研究概览

简要总结

This case series will evaluate the effectiveness of injectable hyaluronic acid combined with polynucleotides as an adjunct to coronally advanced flap and connective tissue graft in patients with RT II gingival recession. Twelve patients will be included and followed for 6 months. Clinical outcomes will include percentage of root coverage, clinical attachment level gain, gingival thickness, probing depth, width of keratinized tissue, post-operative pain, and patient aesthetic satisfaction.

详细描述

Patients with RT II gingival recession will be treated using a coronally advanced flap combined with a de-epithelialized connective tissue graft. Approximately 1-2 mL of a hyaluronic acid and polynucleotide mixture will be applied to the graft before suturing. Patients will be followed for 6 months. Clinical measurements will include recession depth and width, percentage of root coverage, clinical attachment level, gingival thickness, probing depth, keratinized tissue width, post-operative pain, and patient esthetic satisfaction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with RT II gingival recession.
  • Age range: 15-60 years.
  • Systemically healthy patients with no contraindications to surgery.
  • Patients who have not had previous periodontal surgery in the area of treatment.

排除标准

  • Periodontitis.
  • Active systemic disease affecting wound healing.
  • Pregnancy or breastfeeding.
  • Improperly aligned teeth or teeth with cervical restorations or crowns.
  • Non-carious cervical lesions

研究组 & 干预措施

CAF + CTG + Hyaluronic Acid and Polynucleotides

Experimental

Participants with RT II gingival recession will receive coronally advanced flap surgery with a de-epithelialized connective tissue graft combined with hyaluronic acid and polynucleotides.

干预措施: Coronally Advanced Flap with Connective Tissue Graft and Hyaluronic Acid/Polynucleotides (Procedure)

结局指标

主要结局

Percentage of Root Coverage

时间窗: Baseline, 1 month, 3 months, and 6 months

Percentage of root coverage will be calculated using the following formula: (Initial Recession Depth - Post-Treatment Recession Depth) / Initial Recession Depth × 100.

Clinical Attachment Level (CAL) Gain

时间窗: Baseline, 3 months, and 6 months

Clinical attachment level will be measured in millimetres using a UNC-15 periodontal probe

次要结局

  • Recession Depth(Baseline, 3 months, and 6 months)
  • Recession Width(Baseline, 3 months, and 6 months)
  • Gingival Thickness(Baseline, 3 months, and 6 months)
  • Probing Depth(Baseline, 3 months, and 6 months)
  • Width of Keratinized Tissue(Baseline, 3 months, and 6 months)
  • Post-Operative Pain(1 week post-surgery)
  • Patient Esthetic Satisfaction(3 months and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

hassan nidal fandi

Master Student - Periodontology

Cairo University

研究点 (1)

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